Kornimate/medical-research-clean huggingface dataset:
do sulphonylureas preserve cortical function during hypoglycaemia?

Conditions: Type 1 Diabetes Mellitus

Summary: to see if using medication called sulphonylureas can help improve symptoms which patients rely on to recognise low blood glucose levels ( hypoglycaemia) and also to see if they can reduce the slowing down in brain function which occurs at hypoglycaemia.

low blood glucose (hypoglycaemia) is the most common and important side effect of insulin treatment for diabetes. most episodes are "mild" and lead to symptoms that alert the individual to raise their blood sugar level by consuming sugar or starch (carbohydrate). the body also responds to low blood sugars by producing hormones such as adrenaline and cortisol, which help to restore blood sugar levels to normal. as the brain relies on sugar for fuel, it does not function properly if blood sugar levels drop too low, resulting in confusion and in extreme cases reduced conscious levels. repeated hypoglycaemia can blunt the protective symptoms and hormonal responses to hypoglycaemia limiting patients' ability to recognise and correct hypoglycaemia, putting them at high risk of even more hypoglycaemia (heller and cryer, 1991). sulphonylureas are tablets used to treat type 2 diabetes that work by stimulating the pancreas to make more insulin. they do this by closing pores called katp channels which are found on the surface of many cells and control the rate of firing of cells. in the pancreas, closing them causes cells to fire and release insulin. however, in other tissues such as in the brain, these channels have a protective function and they open up during times of lack of fuel, such as lack of oxygen or sugar, preventing the cells from firing and putting them into a resting mode which reduces their energy requirement(dunn-meynell, rawson and levin 1998). however, if the brain cells responsible for generating symptoms are put into this resting mode, they may not produce symptoms, which may contribute to hypoglycaemia unawareness.

Eligibility criteria:
inclusion criteria: * age 18-75 * type 1 diabetes (who definition) of at least 5 years duration * history of impaired awareness of hypoglycaemia (capillary glucose readings \ 3 occasions in the past 3 months (those with intact symptoms will be unlikely to show an improvement and would not really benefit from taking any medication intended just to increase symptoms) exclusion criteria: * pregnancy * severe systemic illness * active malignancy * severe complications of diabetes such as severe visual impairment, severe renal impairment, severe symptomatic autonomic neuropathy * untreated ischemic heart disease, recent stroke * lactose intolerance ( the placebo will contain lactose) * very poor diabetes control (hba1c \> 10%) liver disease ( increase in alt / ast \> 3x uln) * chronic kidney disease stage 4 or 5 ( egfr \< 30ml/min) * severe untreated thyroid or adrenal insufficiency ( must be treated and on stable doses for at least 6 weeks)

Keywords: hypoglycaemia type 1 diabetes mellitus
study to evaluate the efficacy and safety of oral difelikefalin (cr845) for moderate to severe pruritus in subjects with notalgia paresthetica (komfort)

Conditions: Pruritus; Notalgia Paresthetica

Summary: this is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (bid) oral difelikefalin (cr845) in adult subjects with notalgia paresthetica and moderate to severe pruritus.

the study will consist of a 37-day screening period, a 7-day run-in period, a 8-week placebo-controlled treatment period followed by a 4-week active extension period and a follow up visit approximately 14 days after the last dose of study drug. all subjects will sign an informed consent form (icf) and undergo screening for study eligibility. subjects will be randomized to receive either placebo or difelikefalin (cr845) tablets at a dose of 2.0 mg, orally bid. intake of the first dose of study drug will be at day 1. subjects who complete the placebo-controlled treatment period of the study will transition into the active extension period upon completion of the week 8 visit assessments. all subjects in the active extension will receive difelikefalin (cr845).

Eligibility criteria:
key inclusion criteria: to be eligible for inclusion into the study, a patient must meet the following criteria: * subject has clinically confirmed diagnosis of active notalgia paresthetica; * subject has a history of chronic pruritus due to notalgia paresthetica; * subject has moderate to severe pruritus; * female subject is not pregnant or nursing during any period of the study. key exclusion criteria: a patient will be excluded from the study if any of the following criteria are met: * subject has pruritus attributed to a cause other than notalgia paresthetica; * subject has any clinically significant medical condition or physical/laboratory/ecg/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.

Keywords: notalgia paresthetica pruritus cr845 chronic itch difelikefalin itch itching generalized pruritus np neuropathic itch
assessment of coronary stenoses using coronary ct-angiography and non-invasive fractional flow reserve measurement.

Conditions: Myocardial Ischemia

Summary: the purpose of this study is to determine whether a novel non-invasive method to estimate coronary blood flow (ffrct) is applicable to evaluate the functional significance of coronary stenoses in non-culprit vessels in a population of patients with recent stemi (st-elevation myocardial infarction) and multivessel disease. the diagnostic performance and reproducibility of ffrct as well as the qualitative and quantitative correlation between ffrct and the regional coronary blood flow will be examined.

coronary computed tomography angiography (ccta) is a non-invasive imaging modality that provides high-resolution images of coronary lesions. ccta shows good diagnostic performance in detecting or excluding coronary artery stenoses, but the severity of the lesions is often overestimated. with invasive coronary angiography (ica) the hemodynamic consequences of obstructive lesions can be estimated using fractional flow reserve measurement (ffr). there is a good correlation between ffr and non-invasive ischemia tests such as stress echocardiography, exercise tolerance test or single photon emission computed tomography (spect). measurement of ffr during ica represents the "gold standard" for assessment of the hemodynamic significance of coronary artery lesions. the major disadvantage of ffr is that it is an invasive measurement, and consequently there is a risk of complications. recently a non-invasive method to determine ffr has been developed (ffrct). ffrct is performed using standard ccta images, and is based on computational fluid dynamics. the hemodynamic consequence of stenotic lesions is determined at rest and under simulated condition of hyperemia. acute myocardial infarction (mi) is divided into stemi and nstemi on the basis of ecg changes. in denmark patients with stemi are treated with primary percutaneous intervention (ppci) of the culprit lesion. any non-culprit lesions are typically assessed with ffr after 3-4 weeks. even though the rate of complications during ica with ffr is low, these complications can be severe. also the procedure is quite resource demanding. thus it would be desirable if it in these patients could be non-invasively evaluated whether further revascularisation is indicated.

Eligibility criteria:
inclusion criteria: * recent stemi and indication for new ica to assess non-culprit lesions exclusion criteria: * contraindications to adenosine * allergy to contrast agent * p-creatinine \> 125 micromol/l * atrial fibrillation * age \< 18 years * pregnancy
stepped care aitbs 2 depression study (ghent)

Conditions: Depressive Disorder, Major; Treatment Resistant Depression; Melancholia

Summary: antidepressant-free unipolar melancholic depressed patients (at least stage 2 treatment-resistant) will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews. because concomitant antidepressant treatment can confound outcome results, all patients will go through a medication washout before entering the study and they will be free from any antidepressant, neuroleptic and mood stabilizer for at least two weeks before entering the treatment protocol. only habitual benzodiazepine agents will be allowed. step 1: patients will be treated with in total 20 accelerated intermittent theta burst stimulation (aitbs) sessions (3000 pulses/session) over the left dorsolateral prefrontal cortex, which will be spread over 4 days. on each stimulation day, a given patient will receive 5 sessions with a between-session delay of 15 minutes. patients will be randomized to receive either the real aitbs or sham treatment (first week). however, the sham group will receive real aitbs treatment with 10 days' time interval. the investigators expect that real aitbs treatment and not sham will result in a significant and clinical meaningful response. step 2: to optimize treatment and reduce relapse following the itbs treatment, in a stepped care approach, all patients then continue with cognitive control training (cct) ten days later. this cct consists of 20 sessions, spread over 4 weeks. patients will be randomized to receive either real cct or a control training. during this follow-up treatment, all patients will be prescribed antidepressant medication (ssri) again. as itbs treatment effects are known to decline over time, the investigators expect that combining aitbs with a follow-up cct therapy will stabilize the clinical effects over time compared to receiving the itbs treatment alone. for baseline comparisons, patients will be closely matched for gender and age with never-depressed, medication-free healthy volunteers. no volunteer will undergo treatment.


Eligibility criteria:
inclusion criteria: * antidepressant-free unipolar major depression with melancholic features * not responding to at least two trials with an antidepressant * aged between 18-65 years old exclusion criteria: * depression with bipolar/psychotic features * dysthymia * severe personality disorders * active substance abuse/dependence within a year prior to inclusion * pregnancy or without effective anticonception for the duration of the trial * ect non-responder * no response to more than 9 antidepressants * any neurological condition * any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker) * any implanted metal device in the head region * current or past history of epilepsy * neurosurgical interventions * known allergic reaction to radiotracers or associated compounds healthy volunteers may be accepted as control subjects.

Keywords: major depressive disorder treatment resistant depression accelerated intermittent thetaburst stimulation cognitive control training neuroimaging
pharmacodynamic, pharmacokinetic, and tolerability study of a liquid form of lubiprostone in adult subjects with chronic idiopathic constipation

Conditions: Chronic Idiopathic Constipation

Summary: to evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.


Eligibility criteria:
inclusion criteria: * medically-confirmed diagnosis of chronic idiopathic constipation * willing to discontinue use of prescribed or over-the-counter (otc) medication that affects gastrointestinal motility during the study * stable dose of selective serotonin re-uptake inhibitors (ssris), serotonin-specific reuptake inhibitor (snris), or monoamine oxidase inhibitors (mao) inhibitors exclusion criteria: * any gastrointestinal (gi) condition, other than constipation, affecting gi motility or defecation. * medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
video-supported medication education for women undergoing in vitro fertilization (ivf): quality of life and psychosocial effects

Conditions: Infertility; In Vitro Fertilization; Psychosocial Support Systems; Quality of Life; Health Education

Summary: reproductive health problems, particularly infertility, affect 48 million couples globally, ranking as the fifth most serious global obstacle for women. infertility can lead to significant psychosocial effects, including stress, anxiety, and depression, with women experiencing these impacts more severely than men. in vitro fertilization (ivf) offers a solution but comes with emotional, physical, and psychosocial challenges, particularly for women, who often experience fatigue, headaches, weight gain, and stress. effective support mechanisms, such as information and education, are crucial in improving the ivf experience. video-assisted educational programs have shown promise in enhancing knowledge and reducing stress during ivf treatment. however, there is a lack of studies evaluating their impact on the quality of life and psychosocial status of women undergoing ivf. this study aims to examine the effect of video-supported training on drug use, quality of life, and psychosocial status of women during ivf treatment, hypothesizing that it will improve quality of life, increase emotional capacity, and reduce anxiety.


Eligibility criteria:
inclusion criteria: * being female * undergoing infertility treatment * aged 18-49 years * owning a tablet, smartphone, or similar device * having internet access * undergoing ivf treatment for the first time exclusion criteria: * previously received controlled ovarian stimulation treatment * patients undergoing frozen embryo transfer * no internet access * refusal to participate in the ivf medication teaching session
effect of acetazolamide on acute mountain sickness in lowlanders older than 40 years

Conditions: Acute Mountain Sickness

Summary: randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing acute mountain sickness in lowlanders older than 40 years travelling from 760 m to 3'100 m.

this is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of acute mountain sickness (ams) in lowlanders older than 40 years travelling to altitude. participants living in the bishkek area, kyrgyzstan (760m), will be transferred by car within 4h to the tuja ashu high altitude clinic (3'100 m), and stay there for 2 days. acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. outcomes will be assessed during the stay at 3'100 m. an interim analysis will be carried out when 80 participants will have completed the study or after the first year. the peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Eligibility criteria:
inclusion criteria: * healthy men and women, age 40-75 yrs, without any disease and need of medication. * born, raised and currently living at low altitude (\<800m). * written informed consent. * kyrgyz ethnicity exclusion criteria: * any active respiratory, cardiovascular or other disease requiring regular treatment or being otherwise relevant for tolerance of hypoxia or altitude exposure. * any condition that may interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day or \>20 pack-years with active smoking during the last 10 years), regular use of alcohol. * allergy to acetazolamide and other sulfonamides.

Keywords: healthy participants older than 40 years altitude prevention acetazolamide
investigation of the effect of food on the bioavailability of a 25 mg empagliflozin tablet as well as assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.

Conditions: Healthy

Summary: investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.


Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects exclusion criteria: 1. any relevant deviation from healthy conditions
exercise and cardiac measures in dialysis patients

Conditions: Sudden Cardiac Death

Summary: background: the impact of the known non-invasive cardiac indices for identification of hemodialysis (hd) patients at high-risk for sudden cardiac death (scd) has not been evaluated. patients: fifty-nine hd patients were randomized into 2 groups. thirty of them (group a-aged 54.6±8.9 years) participated in a supervised training program with stationary bicycles during their hd sessions (3/weekly) for 10 months, while the rest (group b-aged 53.2±6.1 years) remained untrained and were used as controls. study hypothesis: exercise training will affect most of the non-invasive cardiac markers of scd and the total score positively. method: at entry, as well as at the end of the study all subjects underwent a cardiopulmonary exercise testing (estimation of aerobic capacity-vo2peak), an echocardiographic study (lv ejection fraction -lvef evaluation), an ambulatory 24-hour holter monitoring for cardiac autonomic nervous system activity evaluation by time- and frequency- domain heart rate variability (hrv) calculation (measurement of sdnn, mean rr and low to high frequency ratio-lf/hf), a signal-averaged ecg (late potentials-lp documentation) and a submaximal exercise test for microvolt-t-wave alternans (twa) detection.

the identification of patients on hemodialysis (hd) at increased cardiac risk with powerful screening tests and the reduction of factors, which increase the probability of malignant arrhythmias are important for primary prevention of sudden cardiac death (scd). study design: randomized and controlled clinical trial. setting \& participants: fifty-nine hd patients were randomized into exercise training group (group a-30 patients) and controls (group b-29 patients). intervention: group a participated in a 10-month supervised exercise training program during the hd sessions (3/weekly). outcomes: the effects of exercise on the score of the non-invasive cardiac markers for scd risk stratification and on the occurrence of each variable separately. statistical analysis included a two-group comparison of change scores and an analysis of covariance adjusting for baseline. measurements: at entry and the end of the study, in all participants aerobic capacity (vo2peak) and left ventricular ejection fraction (lvef) were estimated, late potentials and t-wave alternans were detected and heart rate variability was calculated. specifically, from the 24-h holter monitoring the standard deviation of all the normal r-r intervals (sdnn), the mean r-r intervals (mean rr), the low (lf) and high (hf) frequency components of the autoregressive power spectrum of the nn intervals and their ratio (lf/hf) were recorded.

Eligibility criteria:
inclusion criteria: * on hd for at least 6 months * in sinus rhythm * able to reach a sufficient workload during ergometry exclusion criteria: * with bundle branch block * unstable hypertension * diabetes mellitus * severe congestive heart failure * recent myocardial infarction * unstable angina

Keywords: exercise dialysis non-invasive cardiac measures exercise trained patients controls
cytosorb® reduction of freee hemoglobin/acute kidney injury (aki) during cardiac surgery

Conditions: Elective Cardiac Surgery

Summary: prospective, multi-center, randomized, blinded, pivotal clinical study. subjects will be randomized in a 1:1 ratio to either standard of care (soc) alone or standard of care plus treatment with the cytosorb® device.

to evaluate the safety and performance of the cytosorb® device to decrease the incidence or severity of acute kidney injury (aki) as defined by kidney disease improving global outcomes (kdigo) clinical practice guideline definition of acute kidney injury when used intraoperatively with cardiopulmonary bypass (cpb) in subjects undergoing cardiac surgery. the objective of using cytosorb® treatment in this setting is to provide clinically meaningful improvements in renal function by mitigation of intraoperative injury by removal of nephrotoxic agents such as pfhb and complement. up to 420 subjects will be enrolled and randomized at a 1:1 ratio at up to 40 investigational sites in the united states.

Eligibility criteria:
inclusion criteria: * scheduled for non-emergent cardiac surgery requiring cpb for i) heart valve replacement with any other procedure, without hypothermic circulatory arrest (hca), or ii) aortic reconstruction with or without another procedure, with hca exclusion criteria: * isolated coronary artery bypass graft * pregnant women * life expectancy of \< 14 days * end stage organ disease * active infection * correction of a congenital heart defect * contraindication to anticoagulation with heparin * minimally invasive surgery implantation (tavi) or transcatheter aortic valve replacement (tavr) * declined informed consent

Keywords: cytosorb device plasma free hemoglobin inflammation extracorporeal cardiopulmonary bypass cardiopulmonary bypass acute kidney injury
study of vip943 in subjects with advanced cd123+ hematologic malignancies

Conditions: Acute Myeloid Leukemia; B-cell Acute Lymphoblastic Leukemia; High-risk Myelodysplastic Syndrome

Summary: dose escalation - determine the maximum tolerated dose (mtd), if possible, or minimum optimal biologic dose (obd), and evaluate the safety and tolerability of vip943 in subjects with advanced cd123+ hematologic malignancies

relapsed or refractory aml, mds, or b-all subjects who are cd123 positive. subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.

Eligibility criteria:
inclusion criteria: * histologically confirmed aml, b-all or mds. subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies. * evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or blood myeloblasts (mds) to allow for assessment of drug activity. * evidence of cd123 expression from a local laboratory. * eastern cooperative oncology group (ecog) performance status of 0 to 2 exclusion criteria: * known central nervous system (cns) metastases and/or carcinomatous meningitis. * clinically significant cardiac disease including congestive heart failure \> new york heart association (nyha) class ii), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.

Keywords: adc hematologic malignancies leukemia cd123 b-all aml mds relapsed/ refractory hematologic diseases bone marrow diseases